Study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
185
Serlopitant Tablets
Placebo Tablets
Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)
Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Time frame: from Baseline to Day 84
Change in Awake Objective Cough Frequency
Awake cough frequency = (total number of cough events during the monitoring period (24-hour interval) the subject is awake)/(Total duration (in hours) for the monitoring period the subject is awake) which is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Time frame: from Baseline to Day 84
Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency
The percentage of participants with ≥ 30% of reduction from baseline in 24-hour cough frequency is the number of participants with ≤-30% change in 24-hour cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Time frame: from Baseline to Day 84
Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency
The percentage of participants with ≥ 30% of reduction from baseline in the awake cough frequency is the number of participants with ≤30% change in awake cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Time frame: from Baseline to Day 84
Change From Baseline in Cough Severity Visual Analog Scale (VAS)
Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Study Site 130
Los Angeles, California, United States
Study Site 128
Mission Viejo, California, United States
Study Site 123
San Diego, California, United States
Study Site 127
San Jose, California, United States
Study Site 131
Stockton, California, United States
Study Site 106
Colorado Springs, Colorado, United States
Study Site 113
Colorado Springs, Colorado, United States
Study Site 108
Denver, Colorado, United States
Study Site 118
Largo, Florida, United States
Study Site 107
Winter Park, Florida, United States
...and 29 more locations
Time frame: from Baseline to Day 84